Changes to the Non-prescription Drug Monograph Attestation Process

Changes to the Non-prescription Drug Monograph Attestation Process

All non-prescription Category IV Monograph product (DINF) applications must include the new monograph attestation form.

Due to unfavorable results of the monograph attestation pilot, Health Canada has put in place processes to ensure that all DINF applications comply with the monograph.

During the review of DINF applications special attention will be given to the acceptability of medicinal and non-medicinal ingredient declarations, acceptability of brand names, acceptability of claims, inclusion of all necessary warning information, etc.

All other components of the DINF application process remain unchanged.